Peri-operative Foot CT Perfusion in CLI Patients

NCT ID: NCT05575778

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-06-30

Brief Summary

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To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia

Detailed Description

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Conditions

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Critical Limb Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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computed tomographic perfusion

The recruited patients would complete both pre- and post-operative computed tomographic perfusion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18 to 80 years old;
* CLI patients with Fontaine grade III-IV or Rutherford grade 4-6 and underwent a successful revascularization;
* Patients completed both pre- and post-operative CTP workups;
* Patients signed the informed consent form and be able to complete the clinical follow-up for 12 months.

Exclusion Criteria

* Patients has participated in other clinical studies;
* Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate\<60 ml/min)
* Any allergic constitution;
* Pregnancy and childbirth;
* Life expectancy\<12 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhijun Bao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wan Zhang, PH.D.

Role: PRINCIPAL_INVESTIGATOR

Huadong Hospital affiliated to Fudan University, Shanghai, China, 200040

Locations

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Hua Dong Hospital Affiliated to Fu Dan University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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2022KW

Identifier Type: -

Identifier Source: org_study_id

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